Patient Medication Information: uses, side effects, how to take - AA-Risedronate DR
What is AA-RISEDRONATE DR used for?
- AA-RISEDRONATE DR is used to treat osteoporosis in postmenopausal women.
How does AA-RISEDRONATE DR work?
AA-RISEDRONATE DR contains the medicinal ingredient risedronate sodium. Risedronate sodium belongs to a class of non-hormonal drugs called bisphosphonates. Bisphosphonates are similar to a molecule naturally made in your body that breaks down bone tissue. AA-RISEDRONATE DR binds to the receptors in your body to prevent the bone from breaking down. This slows down bone loss which can help to reduce the risk of fractures. In many people AA-RISEDRONATE DR helps to increase bone density.
What are the ingredients in AA-RISEDRONATE DR?
Medicinal ingredients: Risedronate sodium hemi-pentahydrate
Non-medicinal ingredients: colloidal silicon dioxide, disodium edetate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, stearic acid, talc, triethyl citrate, yellow ferric oxide
AA-RISEDRONATE DR comes in the following dosage form:
Enteric-coated tablets: 35 mg (yellow).
The AA-RISEDRONATE DR tablet has an enteric coating which delays the release of risedronate until it reaches the small intestine.
Do not use AA-RISEDRONATE DR if:
- you have low levels of calcium in your blood (hypocalcemia)
you are allergic to risedronate sodium or any of the other ingredients in AA-
RISEDRONATE DR (see What are the ingredients in AA-RISEDRONATE DR?)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AA-RISEDRONATE DR. Talk about any health conditions or problems you may have, including if you:
have or have had problems swallowing or have/had problems with your esophagus
(the tube that connects your mouth to your stomach)
- have or have had stomach or digestive problems
- have or have had kidney problems
cannot stand or sit upright for at least 30 minutes (see How to take AA-RISEDRONATE
DR)
are pregnant or breastfeeding
have one of the following risk factors for developing osteonecrosis (bone damage in the jaw):
- have cancer and/or are currently receiving chemotherapy
- are currently having or have had radiotherapy of the head or neck
- have an infection or a lowered immune system (immunosuppression)
- are taking corticosteroids (used to treat inflammation) or cancer drugs such as angiogenesis inhibitors (used to slow down the growth of new blood vessels)
- have diabetes (high blood sugar)
- have poor oral hygiene or dentures that do not fit well
- have or have had pain, swelling or numbness of the jaw or loosening of a tooth
have sores in your mouth. Your healthcare professional may tell you not to take
AA-RISEDRONATE DR until all the sores in your mouth have healed.
- are or have been a smoker
- have or have had poor dental health, teeth or gum disease
- have anemia (low red blood cell count)
- have a blood disorder where your blood cannot form clots in the normal way
Other warnings you should know about:
Gastrointestinal Problems: Taking AA-RISEDRONATE DR incorrectly may cause you to experience problems with your esophagus. Stop taking AA-RISEDRONATE DR and talk to your healthcare professional if you experience difficulty or pain upon swallowing, chest/breastbone pain or new or worsening heartburn. To avoid problems with your esophagus and to allow the drug to reach the stomach, consider the following instructions:
- swallow each tablet of AA-RISEDRONATE DR with a full glass of water.
- do NOT chew or suck the tablet.
- do NOT lie down for at least 30 minutes after taking AA-RISEDRONATE DR.
- do NOT take AA-RISEDRONATE DR at bedtime or before starting your day.
Eye Problems: Drugs like AA-RISEDRONATE DR may cause vision problems. Different parts of your eye may experience inflammation or you may develop an eye infection. Your healthcare professional may end your treatment if they see symptoms of inflammation.
Oral Health: Your healthcare professional should check your mouth and may ask you to see your dentist before you start taking AA-RISEDRONATE DR. Dental work should be done before you start treatment with AA-RISEDRONATE DR. Tell your healthcare professional if you recently had any major dental procedures like an extraction or a root canal. Take good care of your teeth and gums and see the dentist for regular checkups while taking AA-RISEDRONATE DR.
Calcium and Vitamin D: Calcium and vitamin D are also important for strong bones. Your healthcare professional may ask you to take calcium and vitamin D while you are on AA-RISEDRONATE DR.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with AA-RISEDRONATE DR:
- Vitamins, mineral supplements and antacids may contain substances that can stop your body from absorbing AA-RISEDRONATE DR. They include calcium, magnesium, aluminum and iron. Take these medicines at a different time of day than AA-RISEDRONATE DR. Talk to your health care professional about how and when to take these medications.
- Taking AA-RISEDRONATE DR with corticosteroids or cancer drugs like angiogenesis inhibitors may increase your chance of jaw bone problems (osteonecrosis of the jaw).
- Talk to your healthcare professional before taking pain medication like ASA or other non-steroidal anti-inflammatory drugs (NSAIDs) because they may upset your stomach.
How to take AA-RISEDRONATE DR:
- Take AA-RISEDRONATE DR exactly as your healthcare professional tells you to.
On the same day each week, take AA-RISEDRONATE DR in the morning with breakfast
(including high fat foods, coffee, tea, milk, orange juice etc.). Do not take AA-RISEDRONATE DR before food or on an empty stomach as it may cause abdominal pain.
- Swallow each AA-RISEDRONATE DR tablet whole, while you are sitting or standing in an upright position. Do not chew, cut or crush the tablets or break the outer coating. Drink enough plain water (at least 120 mL or ½ cup) to make sure the tablet gets to your stomach.
- Do not lie down for at least 30 minutes after taking AA-RISEDRONATE DR.
Usual dose:
- 1 AA-RISEDRONATE DR 35 mg tablet per week
Overdose:
If you think you, or a person you are caring for, have taken too much AA-RISEDRONATE DR, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you forget to take your AA-RISEDRONATE DR on your usual day take it in the morning after you remember. You can go back to your regular schedule for the next dose. If you have missed your dose by 1 week do not take two tablets on the same day. Skip your missed dose and go back to your regular schedule.
What are possible side effects from using AA-RISEDRONATE DR?
These are not all the possible side effects you may have when taking AA-RISEDRONATE DR. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- abdominal pain, heartburn, nausea, vomiting
- diarrhea, constipation
- stuffy nose, sore throat
Serious side effects and what to do about them
| Talk to your healthcare | Stop taking drug and | ||
| Symptom / effect | professional | get immediate | |
| Only if | In all | medical help | |
| severe | cases | ||
| COMMON | |||
| Pain in bones, joints or muscles | √ | ||
| Esophagus and stomach problems: abdominal pain, pain or trouble swallowing, vomiting blood, heartburn, chest/breastbone pain, black or bloody stool | √ | ||
| UNCOMMON | |||
Serious side effects and what to do about them
| Talk to your healthcare | Stop taking drug and | ||
| Symptom / effect | professional | get immediate | |
| Only if | In all | medical help | |
| severe | cases | ||
| Eye problems: eye pain, redness or swelling, sensitivity to light, decreased vision | √ | ||
| RARE | |||
| Pain in your tongue | √ | ||
Jaw bone problems (osteonecrosis): numbness or a feeling of heaviness in the jaw; poor healing of gums; loose teeth; exposed bone in the mouth; sores in the mouth; discharge; dry mouth; swelling gums; infections; bad breath; pain in the mouth, teeth or jaw | √ | ||
| VERY RARE | |||
| Allergic reactions: hives, rash (with or without blisters); swelling of the face, lips, tongue or throat; difficult or painful swallowing; trouble breathing | √ | ||
Hypocalcemia (low levels of calcium in the blood): numbness, tingling or muscle spasms | √ | ||
| Atypical femur fracture: new or unusual pain in the hip, groin or thigh | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
If you want more information about AA-RISEDRONATE DR:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.